December 18, 2020

The U.S. FDA has approved a new indication for Tagrisso® (osimertinib), manufactured by AstraZeneca. The drug is now indicated to provide adjuvant treatment following tumor resection in adult patients who have non-small cell lung cancer (NSCLC). Under the new indication, the patient’s tumors must have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. Tagrisso is the first FDA-approved adjuvant therapy for this indication.

NSCLC accounts for most lung cancers diagnosed in the United States. About 20% of patients with NSCLC will have EGFR-positive tumors, which is associated with more aggressive disease. However, about 30% of these individuals have resectable disease – meaning that the cancerous tumors can be removed via surgery. Adjuvant therapy is therapy administered following initial treatment for cancer, often with the intent to suppress secondary tumor development.

In a clinical trial, Tagrisso reduced the risk of disease recurrence by 80% compared to placebo and standard adjuvant chemotherapy. Participants in the trial had undergone complete tumor removal prior to beginning adjuvant treatment.

Recommended dosing under the new indication is 80mg taken by mouth once daily, without or without food, for up to three years or until disease progression or unacceptable toxicity occur.

First FDA approved in 2015, Tagrisso is also indicated as an initial treatment for certain patients who have EGFR-positive metastatic NSCLC, and to treat certain patients whose EGFR-positive metastatic NSCLC has progressed on or after EGFR TKI therapy.

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